Month: May 2007

GSK admit that Seroxat can double the risk of heart defects and other malformations in babies born to Mothers ingesting Seroxat during pregnancy. This has been well documented already and the FDA and MHRA have issued warnings recently about the risks to newborns and the unborn.
There is also much documentation and research about babies suffering withdrawal and other side effects from exposure to Seroxat. But this is still a relatively new issue and there hasn’t been a lot of coverage of these terrible tragedies or these issues in the mainstream media ( although there is a lot of info on the internet about it).. It is a sensitive issue, but I feel it is one that needs to be explored further…

Seroxat was also recently reclassified from a category C drug to a category D…
Which means it does “officially” pose a significant risk to the foetus…

But… In this post I am going to concentrate on some other interesting information relating to Seroxat in the womb , and what I am interested in also is; how do we relate the malformations in newborns to the affects on adult use of Seroxat?

Well, you will notice that from a Seroxat study from the EMC website , there is an interesting fact about Seroxat’s effects on pups (baby rats)…
There was increased pup mortality ( dead baby rats) and also delayed ossification (delayed development/fusion of bones) was observed in the pups..
You can see from the links that problems with Ossification has actually happened to babies born with Seroxat induced defects …

When the seams of the skull close prematurely ( they fail to fuse or ossify) it is called craniosynotosis

Could this development of craniosytosis possibly be related to the severe headaches and head pressure documented in Seroxat withdrawal cases in adults?

What is craniosynotosis?

Craniosynostosis is the term for a group of conditions in which a baby’s head develops abnormally because the seams between the bones close prematurely. This prevents the head from developing normally and may be associated with changes in the upper facial bones. Craniosynostosis can usually be recognized at birth, but for a very small number of children it does not become obvious until one year of age or older.

Why was this not noted and explored further? and why did GSK not draw attention to this? Why was this dismissed?

Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility. In rats, increased pup mortality and delayed ossification were observed. The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate. So , how does this relate to adults? …

Well, considering the drugs affects on the foetus can be seen as an indication that Seroxat can damage the Skull, the internal organs and cause breathing problems in neonates…. surely similar effects could happen in adult use of Seroxat?

Another example of how we can relate the problems seroxat causes in babies , is the evidence of babies born with PPHN (Persistent pulmonary hypertension) from exposure to Seroxat in the womb. PPHN is a life-threatening condition that typically involves severe respiratory failure in a newborn infant and requires immediate treatment.

Would this explain the breathing problems which have been reported extensively by adults suffering Seroxat withdrawal affects?…

There has also been widespread reporting of Seroxat affecting male fertility…

This was also reported in rats ..

(See Links At Bottom Of Post)

Fertility

Animal studies in rats found impaired pregnancy rates at high concentrations. High doses over many weeks led to irreversible atrophic changes in the seminiferous tubules of male rats.

Why has more attention not been brought to Paroxetine’s effects on rats, babies, in the womb and its relation to how it affects adults… ?

Like this:

In this post I am going to compare the differences and changes between the current (2006) Seroxat PIL ( Patient Information Leaflet) and the PIL from twelve years ago (1996)

There is an earlier one from 1991 ( But it is sensitive information apparantly and I cannot post about it)

So, I will focus mainly here on some key points from these two PIL’s. You will notice the differences between them and how the side effect profile of seroxat has increased massively in size in a decade, it is really quite remarkable. Just reading the sheer volume of “official” Seroxat side effects added to the 2006 PIL would make anyone feel depressed or anxious… ( not to mention dizzy and nauseous) (My comments will be in brackets in italics after each point)

PIL 1996

:

What is “Seroxat”?

Everyone has a substance called Serotonin in their body. Low levels of Serotonin are thought to be a cause of Depression and other related conditions. This medicine works by bringing the levels of serotonin back to normal. ( Unproven pseudoscience nonsense )

Seroxat works by relieving symptoms of depression and any associated anxiety. It also treats obsessions , compulsions and panic attacks. These tablets are not addictive. Most people find that Seroxat does not affect their daily lives . ( Not Classed as Addictive, but does cause Dependence which is Addiction , and does cause withdrawal which is a criteria of physically addictive substances )

The usual dose to treat depression is 20mg a day but your doctor may tell you to take up to 50mg a day.
Some people find that if they suddenly stop taking these tablets they feel dizzy, shaky, sick, anxious, confused or have tingling sensations. They also may have difficulty sleeping, and have vivid dreams when they do sleep. But these symptoms are unusual and generally disappear after a few days. ( never proven to work over 20mg )

If you stop taking your tablets too soon your symptoms may return. Remember you cannot become addicted to Seroxat. ( Symptoms such as withdrawal? You can become addicted to Seroxat )

Does “Seroxat: cause side effects? Any medicine can cause unwanted effects, with Seroxat any side effects are usually mild and go away after a few weeks. The most likely side effect of seroxat is that you might feel slightly sick. When taking Seroxat some people may find they have an upset stomach, a rash, or dry mouth. They may sweat more than usual or feel drowsy but unable to sleep soundly. They may also lose their appetite or become constipated. Men may have difficluty having an erection and may find it difficult to ejaculate. All of these side effects will go away once you stop taking the tablets. ( some of these side effects are permanent)

Patients can occasionalyy feel dizzy, shaky or restless or they may feel faint when they stand up. Very rarely patients may feel fascial, body or muscle spasms or sudden mood changes. ( This is very common, NOT very rare )

Depression is a common illness. At any one time one in 20 people will be suffering from it.The balance of chemicals in the brain is thought to affect the way we feel. Serotonin is one of these chemicals and also thought to be low in people who are depressed.

It is important that even when you feel better , you continue taking these tablets until your doctor tells you to stop. This will reduce the chance of your depression returning. ( GSK wanted you to take this stuff for a long time)

PIL 2006

:

Seroxat treats depression and anxiety disorders. Like all medicines it can have unwanted effects.It is therfore impotant that you and your doctor weigh up the benefits of treatment against the possible unwanted affects, before starting treatment. ( the risks clearly outweigh the so called “benefits”)

If you stop or miss a does you may get withdrawal affects

If you feel restless and like you cant sit or stand still tell your doctor

Abnormal production of breast mik in both men and women
A slow heartbeat
Effects on the liver showing up in blod tests of your liver function
Panic Attacks
Overactive thoughts and behaviours (mania)
Feeling detatched from yourself ( depersonalization)
Feeling anxious
Pain in the joints or muscles

Likely to affect up to 1 in 10,000 people

Liver problems that make the skin or whites of the eyes go yellow
Fluid or water retention which may cause swelling of the arms and legs
Sensitivity to sunlight
Painful erection of the penis that wont go away
Unexpected bleeding .eg. Bleeding gums , blood in the urine or in vomit or the appearance of unexpected
bruises or borken blood vessels
Some patients have developed buzzing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take seroxat

Seroxat is a treatment for adults with depression and anxiety disorders. It is not fully understood how Seroxat and other SSRI’s work but they may help by increaing the level of serotonin in the brain.
Other medicines or psychotherapy can also treat depression or anxiety. ( Seroxat is a lobotomy in pill form)